Changes Other than Editing from Proposed to Adopted Version: Language Changes: The adopted rules include the
following changes from the proposed rules published as WSR
11-03-063.

• Pain management -- Intent, WAC 246-919-850 and
246-918-800. Language is added to clarify the
commission's intent and philosophy for the rules.
In WAC 246-918-800 language is added to clarify that
these rules do not restrict the current scope of
practice for the physician assistant or the working
agreement between the physician assistant and the
physician, which may include pain management.

• Long-acting opioids, including methadone, WAC 246-919-858 and 246-918-808. In the third sentence,
after "one-time," "(lifetime)" is added.

• Consultation: Recommendations and requirements, WAC 246-919-860(1) and 246-918-810(1). The words "and
document the consideration" are added to clarify
that the physician and physician assistant must also
document the consideration to refer a patient.

• Consultation: Recommendations and requirements, WAC 246-919-860(2) and 246-918-810(2). The word "adult"
is added to clarify the morphine equivalent dose
(MED) threshold is for adults. The word "oral" is
also added to clarify that the threshold is based on
an "oral" dose. Language regarding pediatric
patients is also added at the end of the paragraph:
"Great caution should be used when prescribing
opioids to children with chronic noncancer pain and
appropriate referrals to a specialist is
encouraged."

• Pain management specialist, WAC 246-919-863
(1)(d)(ii) and 246-918-813 (1)(d)(ii). Language is
added to clarify the cycle in which to complete the
required continuing education is two years for
physicians and three years for osteopathic
physicians.

• Pain management specialist, WAC 246-919-863
(1)(d)(iii) and (3)(d) and 246-918-813 (1)(d)(iii)
and (3)(d). Language is added to clarify that the
current practice may also be in a multidisciplinary
pain clinic setting.

The adopted rules also include edits for grammar,
punctuation, and formatting.

Pain ManagementNEW SECTIONWAC 246-918-800
Pain management -- Intent.
These rules
govern the use of opioids in the treatment of patients for
chronic noncancer pain.

Nothing in these rules in any way restricts the current
scope of practice of physician assistants as set forth in
chapters 18.71A and 18.57A RCW and the working agreements
between the physician and physician assistant, which may
include pain management.

The Washington state medical quality assurance commission
(commission) recognizes that principles of quality medical
practice dictate that the people of the state of Washington
have access to appropriate and effective pain relief. The
appropriate application of up-to-date knowledge and treatment
modalities can serve to improve the quality of life for those
patients who suffer from pain as well as reduce the morbidity
and costs associated with untreated or inappropriately treated
pain. For the purposes of this rule, the inappropriate
treatment of pain includes nontreatment, undertreatment,
overtreatment, and the continued use of ineffective
treatments.

The diagnosis and treatment of pain is integral to the
practice of medicine. The commission encourages physician
assistants to view pain management as a part of quality
medical practice for all patients with pain, acute or chronic,
and it is especially urgent for patients who experience pain
as a result of terminal illness. All physician assistants
should become knowledgeable about assessing patients' pain and
effective methods of pain treatment, as well as statutory
requirements for prescribing controlled substances.
Accordingly, this rule has been developed to clarify the
commission's position on pain control, particularly as related
to the use of controlled substances, to alleviate physician
assistant uncertainty and to encourage better pain management.

Inappropriate pain treatment may result from a physician
assistant's lack of knowledge about pain management. Fears of
investigation or sanction by federal, state, and local
agencies may also result in inappropriate treatment of pain.
Appropriate pain management is the treating physician
assistant's responsibility. As such, the commission will
consider the inappropriate treatment of pain to be a departure
from standards of practice and will investigate such
allegations, recognizing that some types of pain cannot be
completely relieved, and taking into account whether the
treatment is appropriate for the diagnosis.

The commission recognizes that controlled substances
including opioid analgesics may be essential in the treatment
of acute pain due to trauma or surgery and chronic pain,
whether due to cancer or noncancer origins. The commission
will refer to current clinical practice guidelines and expert
review in approaching cases involving management of pain. The
medical management of pain should consider current clinical
knowledge and scientific research and the use of pharmacologic
and nonpharmacologic modalities according to the judgment of
the physician assistant. Pain should be assessed and treated
promptly, and the quantity and frequency of doses should be
adjusted according to the intensity, duration of the pain, and
treatment outcomes. Physician assistants should recognize
that tolerance and physical dependence are normal consequences
of sustained use of opioid analgesics and are not the same as
addiction.

The commission is obligated under the laws of the state
of Washington to protect the public health and safety. The
commission recognizes that the use of opioid analgesics for
other than legitimate medical purposes poses a threat to the
individual and society and that the inappropriate prescribing
of controlled substances, including opioid analgesics, may
lead to drug diversion and abuse by individuals who seek them
for other than legitimate medical use. Accordingly, the
commission expects that physician assistants incorporate
safeguards into their practices to minimize the potential for
the abuse and diversion of controlled substances.

Physician assistants should not fear disciplinary action
from the commission for ordering, prescribing, dispensing or
administering controlled substances, including opioid
analgesics, for a legitimate medical purpose and in the course
of professional practice. The commission will consider
prescribing, ordering, dispensing or administering controlled
substances for pain to be for a legitimate medical purpose if
based on sound clinical judgment. All such prescribing must
be based on clear documentation of unrelieved pain. To be
within the usual course of professional practice, a physician
assistant-patient relationship must exist and the prescribing
should be based on a diagnosis and documentation of unrelieved
pain. Compliance with applicable state or federal law is
required.

The commission will judge the validity of the physician
assistant's treatment of the patient based on available
documentation, rather than solely on the quantity and duration
of medication administration. The goal is to control the
patient's pain while effectively addressing other aspects of
the patient's functioning, including physical, psychological,
social, and work-related factors.

These rules are designed to assist practitioners in
providing appropriate medical care for patients. They are not
inflexible rules or rigid practice requirements and are not
intended, nor should they be used, to establish a legal
standard of care outside the context of the medical quality
assurance committee's jurisdiction.

The ultimate judgment regarding the propriety of any
specific procedure or course of action must be made by the
practitioner based on all the circumstances presented. Thus,
an approach that differs from the rules, standing alone, does
not necessarily imply that the approach was below the standard
of care. To the contrary, a conscientious practitioner may
responsibly adopt a course of action different from that set
forth in the rules when, in the reasonable judgment of the
practitioner, such course of action is indicated by the
condition of the patient, limitations of available resources,
or advances in knowledge or technology subsequent to
publication of these rules. However, a practitioner who
employs an approach substantially different from these rules
is advised to document in the patient record information
sufficient to justify the approach taken.

The practice of medicine involves not only the science,
but also the art of dealing with the prevention, diagnosis,
alleviation, and treatment of disease. The variety and
complexity of human conditions make it impossible to always
reach the most appropriate diagnosis or to predict with
certainty a particular response to treatment.

Therefore, it should be recognized that adherence to
these rules will not assure an accurate diagnosis or a
successful outcome. The sole purpose of these rules is to
assist practitioners in following a reasonable course of
action based on current knowledge, available resources, and
the needs of the patient to deliver effective and safe medical
care.

[]

NEW SECTIONWAC 246-918-801
Exclusions.
The rules adopted under WAC 246-918-800 through 246-918-813 do not apply:

(1) To the provision of palliative, hospice, or other
end-of-life care; or

(2) To the management of acute pain caused by an injury
or surgical procedure.

[]

NEW SECTIONWAC 246-918-802
Definitions.
The definitions in this
section apply in WAC 246-918-800 through 246-918-813 unless
the context clearly requires otherwise.

(1) "Acute pain" means the normal, predicted
physiological response to a noxious chemical, thermal, or
mechanical stimulus and typically is associated with invasive
procedures, trauma, and disease. It is generally
time-limited, often less than three months in duration, and
usually less than six months.

(2) "Addiction" means a primary, chronic, neurobiologic
disease with genetic, psychosocial, and environmental factors
influencing its development and manifestations. It is
characterized by behaviors that include:

(a) Impaired control over drug use;

(b) Craving;

(c) Compulsive use; or

(d) Continued use despite harm.

(3) "Chronic noncancer pain" means a state in which
noncancer pain persists beyond the usual course of an acute
disease or healing of an injury, or that may or may not be
associated with an acute or chronic pathologic process that
causes continuous or intermittent pain over months or years.

(4) "Comorbidity" means a preexisting or coexisting
physical or psychiatric disease or condition.

(5) "Episodic care" means medical care provided by a
practitioner other than the designated primary care
practitioner in the acute care setting, for example, urgent
care or emergency department.

(6) "Hospice" means a model of care that focuses on
relieving symptoms and supporting patients with a life
expectancy of six months or less. Hospice involves an
interdisciplinary approach to provide health care, pain
management, and emotional and spiritual support. The emphasis
is on comfort, quality of life and patient and family support.
Hospice can be provided in the patient's home as well as
freestanding hospice facilities, hospitals, nursing homes, or
other long-term care facilities.

(7) "Morphine equivalent dose" means a conversion of
various opioids to a morphine equivalent dose by the use of
accepted conversion tables.

(9) "Palliative" means care that improves the quality of
life of patients and their families facing life-threatening
illness. With palliative care particular attention is given
to the prevention, assessment, and treatment of pain and other
symptoms, and to the provision of psychological, spiritual,
and emotional support.

[]

NEW SECTIONWAC 246-918-803
Patient evaluation.
The physician
assistant shall obtain, evaluate, and document the patient's
health history and physical examination in the health record
prior to treating for chronic noncancer pain.

(1) The patient's health history shall include:

(a) Current and past treatments for pain;

(b) Comorbidities; and

(c) Any substance abuse.

(2) The patient's health history should include:

(a) A review of any available prescription monitoring
program or emergency department-based information exchange;
and

(b) Any relevant information from a pharmacist provided
to the physician assistant.

(e) A risk screening of the patient for potential
comorbidities and risk factors using an appropriate screening
tool. The screening should address:

(i) History of addiction;

(ii) Abuse or aberrant behavior regarding opioid use;

(iii) Psychiatric conditions;

(iv) Regular concomitant use of benzodiazepines, alcohol,
or other central nervous system medications;

(v) Poorly controlled depression or anxiety;

(vi) Evidence or risk of significant adverse events,
including falls or fractures;

(vii) Receipt of opioids from more than one prescribing
practitioner or practitioner group;

(viii) Repeated visits to emergency departments seeking
opioids;

(ix) History of sleep apnea or other respiratory risk
factors;

(x) Possible or current pregnancy; and

(xi) History of allergies or intolerances.

(4) The initial patient evaluation should include:

(a) Any available diagnostic, therapeutic, and laboratory
results; and

(b) Any available consultations.

(5) The health record shall be maintained in an
accessible manner, readily available for review, and should
include:

(a) The diagnosis, treatment plan, and objectives;

(b) Documentation of the presence of one or more
recognized indications for the use of pain medication;

(c) Documentation of any medication prescribed;

(d) Results of periodic reviews;

(e) Any written agreements for treatment between the
patient and the physician assistant; and

(f) The physician assistant's instructions to the
patient.

[]

NEW SECTIONWAC 246-918-804
Treatment plan.
(1) The written
treatment plan shall state the objectives that will be used to
determine treatment success and shall include, at a minimum:

(a) Any change in pain relief;

(b) Any change in physical and psychosocial function; and

(c) Additional diagnostic evaluations or other planned
treatments.

(2) After treatment begins the physician assistant should
adjust drug therapy to the individual health needs of the
patient. The physician assistant shall include indications
for medication use on the prescription and require photo
identification of the person picking up the prescription in
order to fill. The physician assistant shall advise the
patient that it is the patient's responsibility to safeguard
all medications and keep them in a secure location.

(3) Other treatment modalities or a rehabilitation
program may be necessary depending on the etiology of the pain
and the extent to which the pain is associated with physical
and psychosocial impairment.

[]

NEW SECTIONWAC 246-918-805
Informed consent.
The physician
assistant shall discuss the risks and benefits of treatment
options with the patient, persons designated by the patient,
or with the patient's surrogate or guardian if the patient is
without health care decision-making capacity.

[]

NEW SECTIONWAC 246-918-806
Written agreement for treatment.
Chronic noncancer pain patients should receive all chronic
pain management prescriptions from one physician assistant and
one pharmacy whenever possible. If the patient is at high
risk for medication abuse, or has a history of substance
abuse, or psychiatric comorbidities, the prescribing physician
assistant shall use a written agreement for treatment with the
patient outlining patient responsibilities. This written
agreement for treatment shall include:

(1) The patient's agreement to provide biological samples
for urine/serum medical level screening when requested by the
physician assistant;

(2) The patient's agreement to take medications at the
dose and frequency prescribed with a specific protocol for
lost prescriptions and early refills;

(3) Reasons for which drug therapy may be discontinued
(e.g., violation of agreement);

(4) The requirement that all chronic pain management
prescriptions are provided by a single prescriber or
multidisciplinary pain clinic and dispensed by a single
pharmacy or pharmacy system;

(5) The patient's agreement to not abuse alcohol or use
other medically unauthorized substances;

(6) A written authorization for:

(a) The physician assistant to release the agreement for
treatment to local emergency departments, urgent care
facilities, and pharmacies; and

(b) Other practitioners to report violations of the
agreement back to the physician assistant;

(7) A written authorization that the physician assistant
may notify the proper authorities if he or she has reason to
believe the patient has engaged in illegal activity;

(8) Acknowledgment that a violation of the agreement may
result in a tapering or discontinuation of the prescription;

(9) Acknowledgment that it is the patient's
responsibility to safeguard all medications and keep them in a
secure location; and

(10) Acknowledgment that if the patient violates the
terms of the agreement, the violation and the physician
assistant's response to the violation will be documented, as
well as the rationale for changes in the treatment plan.

[]

NEW SECTIONWAC 246-918-807
Periodic review.
The physician
assistant shall periodically review the course of treatment
for chronic noncancer pain, the patient's state of health, and
any new information about the etiology of the pain.
Generally, periodic reviews shall take place at least every
six months. However, for treatment of stable patients with
chronic noncancer pain involving nonescalating daily dosages
of forty milligrams of a morphine equivalent dose (MED) or
less, periodic reviews shall take place at least annually.

(1) During the periodic review, the physician assistant
shall determine:

(a) Patient's compliance with any medication treatment
plan;

(b) If pain, function, or quality of life have improved
or diminished using objective evidence, considering any
available information from family members or other caregivers;
and

(c) If continuation or modification of medications for
pain management treatment is necessary based on the physician
assistant's evaluation of progress towards treatment
objectives.

(2) The physician assistant shall assess the
appropriateness of continued use of the current treatment plan
if the patient's progress or compliance with current treatment
plan is unsatisfactory. The physician assistant shall
consider tapering, changing, or discontinuing treatment when:

(a) Function or pain does not improve after a trial
period;

(b) There is evidence of significant adverse effects;

(c) Other treatment modalities are indicated; or

(d) There is evidence of misuse, addiction, or diversion.

(3) The physician assistant should periodically review
information from any available prescription monitoring program
or emergency department-based information exchange.

(4) The physician assistant should periodically review
any relevant information from a pharmacist provided to the
physician assistant.

[]

NEW SECTIONWAC 246-918-808
Long-acting opioids, including
methadone.
Long-acting opioids, including methadone, should
only be prescribed by a physician assistant who is familiar
with its risks and use, and who is prepared to conduct the
necessary careful monitoring. Special attention should be
given to patients who are initiating such treatment. A
physician assistant prescribing long-acting opioids or
methadone should have a one-time (lifetime) completion of at
least four continuing education hours relating to this topic.

[]

NEW SECTIONWAC 246-918-809
Episodic care.
(1) When evaluating
patients for episodic care, such as emergency or urgent care,
the physician assistant should review any available
prescription monitoring program, emergency department-based
information exchange, or other tracking system.

(2) Episodic care practitioners should avoid providing
opioids for chronic pain management. However, if opioids are
provided, the practitioner should limit the use of opioids for
a chronic noncancer pain patient to the minimum amount
necessary to control the pain until the patient can receive
care from a primary care practitioner.

(3) Prescriptions for opioids written by an episodic care
practitioner shall include indications for use or the
International Classification of Diseases (ICD) code and shall
be written to require photo identification of the person
picking up the prescription in order to fill.

(4) If a patient has signed a written agreement for
treatment and has provided a written authorization to release
the agreement under WAC 246-918-806(6) to episodic care
practitioners, then the episodic care practitioner should
report known violations of the agreement back to the patient's
treatment practitioner who provided the agreement for
treatment.

[]

NEW SECTIONWAC 246-918-810
Consultation -- Recommendations and
requirements.
(1) The physician assistant shall consider, and
document the consideration, referring the patient for
additional evaluation and treatment as needed to achieve
treatment objectives. Special attention should be given to
those chronic noncancer pain patients who are under eighteen
years of age, or who are at risk for medication misuse, abuse,
or diversion. The management of pain in patients with a
history of substance abuse or with comorbid psychiatric
disorders may require extra care, monitoring, documentation,
and consultation with, or referral to, an expert in the
management of such patients.

(2) The mandatory consultation threshold for adults is
one hundred twenty milligrams morphine equivalent dose
(MED)(oral). In the event a practitioner prescribes a dosage
amount that meets or exceeds the consultation threshold of one
hundred twenty milligrams MED (orally) per day, a consultation
with a pain management specialist as described in WAC 246-918-813 is required, unless the consultation is exempted
under WAC 246-918-811 or 246-918-812. Great caution should be
used when prescribing opioids to children with chronic
noncancer pain and appropriate referrals to a specialist is
encouraged.

(a) The mandatory consultation shall consist of at least
one of the following:

(i) An office visit with the patient and the pain
management specialist;

(ii) A telephone consultation between the pain management
specialist and the physician assistant;

(iii) An electronic consultation between the pain
management specialist and the physician assistant; or

(iv) An audio-visual evaluation conducted by the pain
management specialist remotely, where the patient is present
with either the physician assistant or a licensed health care
practitioner designated by the physician assistant or the pain
management specialist.

(b) A physician assistant shall document each mandatory
consultation with the pain management specialist. Any written
record of the consultation by the pain management specialist
shall be maintained as a patient record by the specialist. If
the specialist provides a written record of the consultation
to the physician assistant, the physician assistant shall
maintain it as part of the patient record.

(3) Nothing in this chapter shall limit any person's
ability to contractually require a consultation with a pain
management specialist at any time. For the purposes of WAC 246-918-800 through 246-918-813, "person" means an individual,
a trust or estate, a firm, a partnership, a corporation
(including associations, joint stock companies, and insurance
companies), the state, or a political subdivision or
instrumentality of the state, including a municipal
corporation or a hospital district.

[]

NEW SECTIONWAC 246-918-811
Consultation -- Exemptions for exigent
and special circumstances.
A physician assistant is not
required to consult with a pain management specialist as
described in WAC 246-918-813 when he or she has documented
adherence to all standards of practice as defined in WAC 246-918-800 through 246-918-813 when any one or more of the
following conditions apply:

(1) The patient is following a tapering schedule;

(2) The patient requires treatment for acute pain which
may or may not include hospitalization, requiring a temporary
escalation in opioid dosage, with expected return to or below
their baseline dosage level;

(3) The physician assistant documents reasonable attempts
to obtain a consultation with a pain management specialist and
the circumstances justifying prescribing above one hundred
twenty milligrams morphine equivalent dose (MED) per day
without first obtaining a consultation; or

(4) The physician assistant documents that the patient's
pain and function is stable and that the patient is on a
nonescalating dosage of opioids.

[]

NEW SECTIONWAC 246-918-812
Consultation -- Exemptions for the
physician assistant.
The physician assistant is exempt from
the consultation requirement in WAC 246-918-810 if one or more
of the following qualifications are met:

(1) The sponsoring physician is a pain management
specialist under WAC 246-918-813; or

(2) The sponsoring physician and the physician assistant
has successfully completed, within the last two years, a
minimum of twelve continuing education hours (Category 1 for
physicians) on chronic pain management, with at least two of
these hours dedicated to long-acting opioids; or

(3) The physician assistant is a pain management
practitioner working in a multidisciplinary chronic pain
treatment center, or a multidisciplinary academic research
facility.

[]

NEW SECTIONWAC 246-918-813
Pain management specialist.
A pain
management specialist shall meet one or more of the following
qualifications:

(1) If a physician or osteopathic physician:

(a) Board certified or board eligible by an American
Board of Medical Specialties-approved board (ABMS) or by the
American Osteopathic Association (AOA) in physical medicine
and rehabilitation, rehabilitation medicine, neurology,
rheumatology, or anesthesiology; or

(b) Has a subspecialty certificate in pain medicine by an
ABMS-approved board; or

(c) Has a certification of added qualification in pain
management by the AOA; or

(d) A minimum of three years of clinical experience in a
chronic pain management care setting; and

(i) Credentialed in pain management by an entity approved
by the Washington state medical quality assurance commission
for physicians or the Washington state board of osteopathic
medicine and surgery for osteopathic physicians; and

(ii) Successful completion of a minimum of at least
eighteen continuing education hours in pain management during
the past two years for physicians or three years for
osteopathic physicians; and

(iii) At least thirty percent of the physician's or
osteopathic physician's current practice is the direct
provision of pain management care, or is in a
multidisciplinary pain clinic.

(2) If a dentist: Board certified or board eligible in
oral medicine or orofacial pain by the American Board of Oral
Medicine or the American Board of Orofacial Pain.

(3) If an advanced registered nurse practitioner (ARNP):

(a) A minimum of three years of clinical experience in a
chronic pain management care setting;

(b) Credentialed in pain management by the Washington
state nursing care quality assurance commission-approved
national professional association, pain association, or other
credentialing entity;

(c) Successful completion of a minimum of at least
eighteen continuing education hours in pain management during
the past two years; and

(d) At least thirty percent of the ARNP's current
practice is the direct provision of pain management care, or
is in a multidisciplinary pain clinic.

(4) If a podiatric physician:

(a) Board certified or board eligible in a specialty that
includes a focus on pain management by the American Board of
Podiatric Surgery, the American Board of Podiatric Orthopedics
and Primary Podiatric Medicine, or other accredited certifying
board as approved by the Washington state podiatric medical
board; or

(b) A minimum of three years of clinical experience in a
chronic pain management care setting; and

(c) Credentialed in pain management by the Washington
state podiatric medical board-approved national professional
association, pain association, or other credentialing entity;
and

(d) Successful completion of a minimum of at least
eighteen hours of continuing education in pain management
during the past two years, and at least thirty percent of the
podiatric physician's current practice is the direct provision
of pain management care.

[]

OTS-3823.4

Pain ManagementNEW SECTIONWAC 246-919-850
Pain management -- Intent.
These rules
govern the use of opioids in the treatment of patients for
chronic noncancer pain.

The Washington state medical quality assurance commission
(commission) recognizes that principles of quality medical
practice dictate that the people of the state of Washington
have access to appropriate and effective pain relief. The
appropriate application of up-to-date knowledge and treatment
modalities can serve to improve the quality of life for those
patients who suffer from pain as well as reduce the morbidity
and costs associated with untreated or inappropriately treated
pain. For the purposes of this rule, the inappropriate
treatment of pain includes nontreatment, undertreatment,
overtreatment, and the continued use of ineffective
treatments.

The diagnosis and treatment of pain is integral to the
practice of medicine. The commission encourages physicians to
view pain management as a part of quality medical practice for
all patients with pain, acute or chronic, and it is especially
urgent for patients who experience pain as a result of
terminal illness. All physicians should become knowledgeable
about assessing patients' pain and effective methods of pain
treatment, as well as statutory requirements for prescribing
controlled substances. Accordingly, this rule has been
developed to clarify the commission's position on pain
control, particularly as related to the use of controlled
substances, to alleviate physician uncertainty and to
encourage better pain management.

Inappropriate pain treatment may result from a
physician's lack of knowledge about pain management. Fears of
investigation or sanction by federal, state, and local
agencies may also result in inappropriate treatment of pain.
Appropriate pain management is the treating physician's
responsibility. As such, the commission will consider the
inappropriate treatment of pain to be a departure from
standards of practice and will investigate such allegations,
recognizing that some types of pain cannot be completely
relieved, and taking into account whether the treatment is
appropriate for the diagnosis.

The commission recognizes that controlled substances
including opioid analgesics may be essential in the treatment
of acute pain due to trauma or surgery and chronic pain,
whether due to cancer or noncancer origins. The commission
will refer to current clinical practice guidelines and expert
review in approaching cases involving management of pain. The
medical management of pain should consider current clinical
knowledge and scientific research and the use of pharmacologic
and nonpharmacologic modalities according to the judgment of
the physician. Pain should be assessed and treated promptly,
and the quantity and frequency of doses should be adjusted
according to the intensity, duration of the pain, and
treatment outcomes. Physicians should recognize that
tolerance and physical dependence are normal consequences of
sustained use of opioid analgesics and are not the same as
addiction.

The commission is obligated under the laws of the state
of Washington to protect the public health and safety. The
commission recognizes that the use of opioid analgesics for
other than legitimate medical purposes poses a threat to the
individual and society and that the inappropriate prescribing
of controlled substances, including opioid analgesics, may
lead to drug diversion and abuse by individuals who seek them
for other than legitimate medical use. Accordingly, the
commission expects that physicians incorporate safeguards into
their practices to minimize the potential for the abuse and
diversion of controlled substances.

Physicians should not fear disciplinary action from the
commission for ordering, prescribing, dispensing or
administering controlled substances, including opioid
analgesics, for a legitimate medical purpose and in the course
of professional practice. The commission will consider
prescribing, ordering, dispensing or administering controlled
substances for pain to be for a legitimate medical purpose if
based on sound clinical judgment. All such prescribing must
be based on clear documentation of unrelieved pain. To be
within the usual course of professional practice, a
physician-patient relationship must exist and the prescribing
should be based on a diagnosis and documentation of unrelieved
pain. Compliance with applicable state or federal law is
required.

The commission will judge the validity of the physician's
treatment of the patient based on available documentation,
rather than solely on the quantity and duration of medication
administration. The goal is to control the patient's pain
while effectively addressing other aspects of the patient's
functioning, including physical, psychological, social, and
work-related factors.

These rules are designed to assist practitioners in
providing appropriate medical care for patients. They are not
inflexible rules or rigid practice requirements and are not
intended, nor should they be used, to establish a legal
standard of care outside the context of the medical quality
assurance committee's jurisdiction.

The ultimate judgment regarding the propriety of any
specific procedure or course of action must be made by the
practitioner based on all the circumstances presented. Thus,
an approach that differs from the rules, standing alone, does
not necessarily imply that the approach was below the standard
of care. To the contrary, a conscientious practitioner may
responsibly adopt a course of action different from that set
forth in the rules when, in the reasonable judgment of the
practitioner, such course of action is indicated by the
condition of the patient, limitations of available resources,
or advances in knowledge or technology subsequent to
publication of these rules. However, a practitioner who
employs an approach substantially different from these rules
is advised to document in the patient record information
sufficient to justify the approach taken.

The practice of medicine involves not only the science,
but also the art of dealing with the prevention, diagnosis,
alleviation, and treatment of disease. The variety and
complexity of human conditions make it impossible to always
reach the most appropriate diagnosis or to predict with
certainty a particular response to treatment.

Therefore, it should be recognized that adherence to
these rules will not assure an accurate diagnosis or a
successful outcome. The sole purpose of these rules is to
assist practitioners in following a reasonable course of
action based on current knowledge, available resources, and
the needs of the patient to deliver effective and safe medical
care.

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NEW SECTIONWAC 246-919-851
Exclusions.
The rules adopted under WAC 246-919-850 through 246-919-863 do not apply:

(1) To the provision of palliative, hospice, or other
end-of-life care; or

(2) To the management of acute pain caused by an injury
or surgical procedure.

(1) "Acute pain" means the normal, predicted
physiological response to a noxious chemical, thermal, or
mechanical stimulus and typically is associated with invasive
procedures, trauma, and disease. It is generally
time-limited, often less than three months in duration, and
usually less than six months.

(2) "Addiction" means a primary, chronic, neurobiologic
disease with genetic, psychosocial, and environmental factors
influencing its development and manifestations. It is
characterized by behaviors that include:

(a) Impaired control over drug use;

(b) Craving;

(c) Compulsive use; or

(d) Continued use despite harm.

(3) "Chronic noncancer pain" means a state in which
noncancer pain persists beyond the usual course of an acute
disease or healing of an injury, or that may or may not be
associated with an acute or chronic pathologic process that
causes continuous or intermittent pain over months or years.

(4) "Comorbidity" means a preexisting or coexisting
physical or psychiatric disease or condition.

(5) "Episodic care" means medical care provided by a
practitioner other than the designated primary care
practitioner in the acute care setting, for example, urgent
care or emergency department.

(6) "Hospice" means a model of care that focuses on
relieving symptoms and supporting patients with a life
expectancy of six months or less. Hospice involves an
interdisciplinary approach to provide health care, pain
management, and emotional and spiritual support. The emphasis
is on comfort, quality of life and patient and family support.
Hospice can be provided in the patient's home as well as
freestanding hospice facilities, hospitals, nursing homes, or
other long-term care facilities.

(7) "Morphine equivalent dose" means a conversion of
various opioids to a morphine equivalent dose by the use of
accepted conversion tables.

(9) "Palliative" means care that improves the quality of
life of patients and their families facing life-threatening
illness. With palliative care particular attention is given
to the prevention, assessment, and treatment of pain and other
symptoms, and to the provision of psychological, spiritual,
and emotional support.

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NEW SECTIONWAC 246-919-853
Patient evaluation.
The physician shall
obtain, evaluate, and document the patient's health history
and physical examination in the health record prior to
treating for chronic noncancer pain.

(1) The patient's health history shall include:

(a) Current and past treatments for pain;

(b) Comorbidities; and

(c) Any substance abuse.

(2) The patient's health history should include:

(a) A review of any available prescription monitoring
program or emergency department-based information exchange;
and

(b) Any relevant information from a pharmacist provided
to a physician.

(e) A risk screening of the patient for potential
comorbidities and risk factors using an appropriate screening
tool. The screening should address:

(i) History of addiction;

(ii) Abuse or aberrant behavior regarding opioid use;

(iii) Psychiatric conditions;

(iv) Regular concomitant use of benzodiazepines, alcohol,
or other central nervous system medications;

(v) Poorly controlled depression or anxiety;

(vi) Evidence or risk of significant adverse events,
including falls or fractures;

(vii) Receipt of opioids from more than one prescribing
practitioner or practitioner group;

(viii) Repeated visits to emergency departments seeking
opioids;

(ix) History of sleep apnea or other respiratory risk
factors;

(x) Possible or current pregnancy; and

(xi) History of allergies or intolerances.

(4) The initial patient evaluation should include:

(a) Any available diagnostic, therapeutic, and laboratory
results; and

(b) Any available consultations.

(5) The health record shall be maintained in an
accessible manner, readily available for review, and should
include:

(a) The diagnosis, treatment plan, and objectives;

(b) Documentation of the presence of one or more
recognized indications for the use of pain medication;

(c) Documentation of any medication prescribed;

(d) Results of periodic reviews;

(e) Any written agreements for treatment between the
patient and the physician; and

(f) The physician's instructions to the patient.

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NEW SECTIONWAC 246-919-854
Treatment plan.
(1) The written
treatment plan shall state the objectives that will be used to
determine treatment success and shall include, at a minimum:

(a) Any change in pain relief;

(b) Any change in physical and psychosocial function; and

(c) Additional diagnostic evaluations or other planned
treatments.

(2) After treatment begins the physician should adjust
drug therapy to the individual health needs of the patient.
The physician shall include indications for medication use on
the prescription and require photo identification of the
person picking up the prescription in order to fill. The
physician shall advise the patient that it is the patient's
responsibility to safeguard all medications and keep them in a
secure location.

(3) Other treatment modalities or a rehabilitation
program may be necessary depending on the etiology of the pain
and the extent to which the pain is associated with physical
and psychosocial impairment.

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NEW SECTIONWAC 246-919-855
Informed consent.
The physician shall
discuss the risks and benefits of treatment options with the
patient, persons designated by the patient, or with the
patient's surrogate or guardian if the patient is without
health care decision-making capacity.

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NEW SECTIONWAC 246-919-856
Written agreement for treatment.
Chronic noncancer pain patients should receive all chronic
pain management prescriptions from one physician and one
pharmacy whenever possible. If the patient is at high risk
for medication abuse, or has a history of substance abuse, or
psychiatric comorbidities, the prescribing physician shall use
a written agreement for treatment with the patient outlining
patient responsibilities. This written agreement for
treatment shall include:

(1) The patient's agreement to provide biological samples
for urine/serum medical level screening when requested by the
physician;

(2) The patient's agreement to take medications at the
dose and frequency prescribed with a specific protocol for
lost prescriptions and early refills;

(3) Reasons for which drug therapy may be discontinued
(e.g., violation of agreement);

(4) The requirement that all chronic pain management
prescriptions are provided by a single prescriber or
multidisciplinary pain clinic and dispensed by a single
pharmacy or pharmacy system;

(5) The patient's agreement to not abuse alcohol or use
other medically unauthorized substances;

(6) A written authorization for:

(a) The physician to release the agreement for treatment
to local emergency departments, urgent care facilities, and
pharmacies; and

(b) Other practitioners to report violations of the
agreement back to the physician;

(7) A written authorization that the physician may notify
the proper authorities if he or she has reason to believe the
patient has engaged in illegal activity;

(8) Acknowledgment that a violation of the agreement may
result in a tapering or discontinuation of the prescription;

(9) Acknowledgment that it is the patient's
responsibility to safeguard all medications and keep them in a
secure location; and

(10) Acknowledgment that if the patient violates the
terms of the agreement, the violation and the physician's
response to the violation will be documented, as well as the
rationale for changes in the treatment plan.

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NEW SECTIONWAC 246-919-857
Periodic review.
The physician shall
periodically review the course of treatment for chronic
noncancer pain, the patient's state of health, and any new
information about the etiology of the pain. Generally,
periodic reviews shall take place at least every six months.
However, for treatment of stable patients with chronic
noncancer pain involving nonescalating daily dosages of forty
milligrams of a morphine equivalent dose (MED) or less,
periodic reviews shall take place at least annually.

(1) During the periodic review, the physician shall
determine:

(a) Patient's compliance with any medication treatment
plan;

(b) If pain, function, or quality of life have improved
or diminished using objective evidence, considering any
available information from family members or other caregivers;
and

(c) If continuation or modification of medications for
pain management treatment is necessary based on the
physician's evaluation of progress towards treatment
objectives.

(2) The physician shall assess the appropriateness of
continued use of the current treatment plan if the patient's
progress or compliance with current treatment plan is
unsatisfactory. The physician shall consider tapering,
changing, or discontinuing treatment when:

(a) Function or pain does not improve after a trial
period;

(b) There is evidence of significant adverse effects;

(c) Other treatment modalities are indicated; or

(d) There is evidence of misuse, addiction, or diversion.

(3) The physician should periodically review information
from any available prescription monitoring program or
emergency department-based information exchange.

(4) The physician should periodically review any relevant
information from a pharmacist provided to the physician.

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NEW SECTIONWAC 246-919-858
Long-acting opioids, including
methadone.
Long-acting opioids, including methadone, should
only be prescribed by a physician who is familiar with its
risks and use, and who is prepared to conduct the necessary
careful monitoring. Special attention should be given to
patients who are initiating such treatment. The physician
prescribing long-acting opioids or methadone should have a
one-time (lifetime) completion of at least four hours of
continuing education relating to this topic.

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NEW SECTIONWAC 246-919-859
Episodic care.
(1) When evaluating
patients for episodic care, such as emergency or urgent care,
the physician should review any available prescription
monitoring program, emergency department-based information
exchange, or other tracking system.

(2) Episodic care practitioners should avoid providing
opioids for chronic pain management. However, if opioids are
provided, the practitioner should limit the use of opioids for
a chronic noncancer pain patient to the minimum amount
necessary to control the pain until the patient can receive
care from a primary care practitioner.

(3) Prescriptions for opioids written by an episodic care
practitioner shall include indications for use or the
International Classification of Diseases (ICD) code and shall
be written to require photo identification of the person
picking up the prescription in order to fill.

(4) If a patient has signed a written agreement for
treatment and has provided a written authorization to release
the agreement under WAC 246-919-856(6) to episodic care
practitioners, then the episodic care practitioner should
report known violations of the agreement back to the patient's
treatment practitioner who provided the agreement for
treatment.

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NEW SECTIONWAC 246-919-860
Consultation -- Recommendations and
requirements.
(1) The physician shall consider, and document
the consideration, referring the patient for additional
evaluation and treatment as needed to achieve treatment
objectives. Special attention should be given to those
chronic noncancer pain patients who are under eighteen years
of age, or who are at risk for medication misuse, abuse, or
diversion. The management of pain in patients with a history
of substance abuse or with comorbid psychiatric disorders may
require extra care, monitoring, documentation, and
consultation with, or referral to, an expert in the management
of such patients.

(2) The mandatory consultation threshold for adults is
one hundred twenty milligrams morphine equivalent dose
(MED)(oral). In the event a physician prescribes a dosage
amount that meets or exceeds the consultation threshold of one
hundred twenty milligrams MED (orally) per day, a consultation
with a pain management specialist as described in WAC 246-919-863 is required, unless the consultation is exempted
under WAC 246-919-861 or 246-919-862. Great caution should be
used when prescribing opioids to children with chronic
noncancer pain and appropriate referrals to a specialist is
encouraged.

(a) The mandatory consultation shall consist of at least
one of the following:

(i) An office visit with the patient and the pain
management specialist;

(ii) A telephone consultation between the pain management
specialist and the physician;

(iii) An electronic consultation between the pain
management specialist and the physician; or

(iv) An audio-visual evaluation conducted by the pain
management specialist remotely, where the patient is present
with either the physician or a licensed health care
practitioner designated by the physician or the pain
management specialist.

(b) A physician shall document each mandatory
consultation with the pain management specialist. Any written
record of the consultation by the pain management specialist
shall be maintained as a patient record by the specialist. If
the specialist provides a written record of the consultation
to the physician, the physician shall maintain it as part of
the patient record.

(3) Nothing in this chapter shall limit any person's
ability to contractually require a consultation with a pain
management specialist at any time. For the purposes of WAC 246-919-850 through 246-919-863, "person" means an individual,
a trust or estate, a firm, a partnership, a corporation
(including associations, joint stock companies, and insurance
companies), the state, or a political subdivision or
instrumentality of the state, including a municipal
corporation or a hospital district.

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NEW SECTIONWAC 246-919-861
Consultation -- Exemptions for exigent and
special circumstances.
A physician is not required to consult
with a pain management specialist as described in WAC 246-919-863 when he or she has documented adherence to all
standards of practice as defined in WAC 246-919-850 through
246-919-863 and when any one or more of the following
conditions apply:

(1) The patient is following a tapering schedule;

(2) The patient requires treatment for acute pain which
may or may not include hospitalization, requiring a temporary
escalation in opioid dosage, with expected return to or below
their baseline dosage level; or

(3) The physician documents reasonable attempts to obtain
a consultation with a pain management specialist and the
circumstances justifying prescribing above one hundred twenty
milligrams morphine equivalent dose (MED) per day without
first obtaining a consultation; or

(4) The physician documents the patient's pain and
function is stable and the patient is on a nonescalating
dosage of opioids.

[]

NEW SECTIONWAC 246-919-862
Consultation -- Exemptions for the
physician.
The physician is exempt from the consultation
requirement in WAC 246-919-860 if one or more of the following
qualifications are met:

(1) The physician is a pain management specialist under
WAC 246-919-863; or

(2) The physician has successfully completed, within the
last two years, a minimum of twelve (Category I) continuing
education hours on chronic pain management with at least two
of these hours dedicated to long acting opioids; or

(3) The physician is a pain management practitioner
working in a multidisciplinary chronic pain treatment center,
or a multidisciplinary academic research facility; or

(4) The physician has a minimum three years of clinical
experience in a chronic pain management setting, and at least
thirty percent of his or her current practice is the direct
provision of pain management care.

[]

NEW SECTIONWAC 246-919-863
Pain management specialist.
A pain
management specialist shall meet one or more of the following
qualifications:

(1) If a physician or osteopathic physician:

(a) Board certified or board eligible by an American
Board of Medical Specialties-approved board (ABMS) or by the
American Osteopathic Association (AOA) in physical medicine
and rehabilitation, rehabilitation medicine, neurology,
rheumatology, or anesthesiology; or

(b) Has a subspecialty certificate in pain medicine by an
ABMS-approved board; or

(c) Has a certification of added qualification in pain
management by the AOA; or

(d) A minimum of three years of clinical experience in a
chronic pain management care setting; and

(i) Credentialed in pain management by an entity approved
by the Washington state medical quality assurance commission
for physicians or the Washington state board of osteopathic
medicine and surgery for osteopathic physicians; and

(ii) Successful completion of a minimum of at least
eighteen continuing education hours in pain management during
the past two years for physicians or three years for
osteopathic physicians; and

(iii) At least thirty percent of the physician's or
osteopathic physician's current practice is the direct
provision of pain management care or is in a multidisciplinary
pain clinic.

(2) If a dentist: Board certified or board eligible in
oral medicine or orofacial pain by the American Board of Oral
Medicine or the American Board of Orofacial Pain.

(3) If an advanced registered nurse practitioner (ARNP):

(a) A minimum of three years of clinical experience in a
chronic pain management care setting;

(b) Credentialed in pain management by the Washington
state nursing care quality assurance commission-approved
national professional association, pain association, or other
credentialing entity;

(c) Successful completion of a minimum of at least
eighteen continuing education hours in pain management during
the past two years; and

(d) At least thirty percent of the ARNP's current
practice is the direct provision of pain management care or is
in a multidisciplinary pain clinic.

(4) If a podiatric physician:

(a) Board certified or board eligible in a specialty that
includes a focus on pain management by the American Board of
Podiatric Surgery, the American Board of Podiatric Orthopedics
and Primary Podiatric Medicine, or other accredited certifying
board as approved by the Washington state podiatric medical
board; or

(b) A minimum of three years of clinical experience in a
chronic pain management care setting; and

(c) Credentialed in pain management by the Washington
state podiatric medical board-approved national professional
association, pain association, or other credentialing entity;
and

(d) Successful completion of a minimum of at least
eighteen hours of continuing education in pain management
during the past two years, and at least thirty percent of the
podiatric physician's current practice is the direct provision
of pain management care.

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OTS-3705.1

REPEALER

The following sections of the Washington Administrative Code are repealed: